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Neoadjuvant Chemotherapy with Oxaliplatin plus Fluorouracil l-Leucovorin or Oxaliplatin plus Capecitabin and MoAb for resectable colorectal liver metastases(CML) from tokai digestive cancer trials group

Neoadjuvant Chemotherapy with Oxaliplatin plus Fluorouracil l-Leucovorin or Oxaliplatin plus Capecitabin and MoAb for resectable colorectal liver metastases(CML) from tokai digestive cancer trials group - Neoadjuvant Chemotherapy with Oxaliplatin plus Fluorouracil l-Leucovorin or Oxaliplatin plus Capecitabin and MoAb for resectable colorectal liver metastases (COMET)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003796
Enrollment
45
Registered
2010-06-22
Start date
2010-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resectable Liver Metastases From Colorectal Cancer

Interventions

Patients receive FOLFOX regimen or XELOX (oxaliplatin plus capecitabin) and MoAb as neoadjuvant protocol

Sponsors

Epidemiological and Clinical Research Information Network
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1,Histologically confirmed colorectal cancer 2,KRAS mutation status was determined 3,Resectable liver metastases with or without lymphnode metastases 4,No extrahepatic disease 5,No prior chemotherapy , immunotherapy and radiotherapy except adjuvant chemotherapy if ended >=6 months before study entry 6,No prior radiofrequency ablation or surgery for liver metastases 7,No prior radiotherapy for liver metastases 8,ECOG performance status <=1 9,Adequate hematological, renal and liver function 10,Written informed consent

Exclusion criteria

Exclusion criteria: 1,Serious myelosuppression 2.Serious infection 3,Large quantity of abdominal or pleural effusion 4,cardiovascular disease, complication 5,sensory alteration or paresthesia interfering with function 6,No brain or bone metastasis, active double cancer 7,No hypersensitivity for test drugs 8,Serious pulmonary disease 9,Liver cirrhosis 10,Multiple cancer patient

Design outcomes

Primary

MeasureTime frame
Progression-free survival

Secondary

MeasureTime frame
anti-tumor effect overall survival R0 resection rate

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026